[Federal Register: February 12, 2003 (Volume 68, Number 29)]
[Page 7127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: General and Plastic Surgery Devices Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 28, 2003, from 
8 a.m. to 5 p.m.
    Location: Hilton DC North--Gaithersburg, Salons A, B & C, 620 Perry 
Pkwy., Gaithersburg, MD.
    Contact Person: David Krause, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12519. Please call the Information Line or access the 
Internet address of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html for up-to-
date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an injectable wrinkle treatment 
device. There will also be a discussion of two general issues: (1) 
Clinical trial issues for devices designed for ablation of pulmonary 
tumors, and (2) clinical trial issues for devices designed for the 
treatment of emphysema. Background information for each topic, 
including the agenda and questions for the committee, will be available 
to the public 1 business day before the meeting on the Internet at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. The material for this meeting 
will be posted on February 27, 2003.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by February 14, 
2003. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 8:45 a.m., 11:30 a.m. and 11:45 a.m., and 
between approximately 3:30 p.m. and 4 p.m. Time allotted for oral 
public presentations may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 14, 
2003, and submit a brief statement of the general nature of the 
evidence or arguments they wish to present, the names and addresses of 
proposed participants, and an indication of the approximate time 
requested to make their presentation.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 5, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-3430 Filed 2-11-03; 8:45 am]